FDA Begins Review Of Pre-amendments Device Data Submissions

Article perview reprinted from "The Gray Sheet" - August 17, 2009

A friendly reminder to pre-amendments device makers: failing to submit the safety and effectiveness information FDA ordered on 25 device types this April could result in seizure, injunction or even criminal prosecution. Read More...

FDA Begins Review Of Pre-amendments Device Data Submissions

Article perview reprinted from "The Gray Sheet" - August 17, 2009

A friendly reminder to pre-amendments device makers: failing to submit the safety and effectiveness information FDA ordered on 25 device types this April could result in seizure, injunction or even criminal prosecution.

The information submissions on the specified device categories were due to FDA on Aug. 7, though submissions are still rolling into the agency (1 'The Gray Sheet' April 13, 2009). CDRH has received 120 submissions to date, but expects many more.

Philips Healthcare, for example, maker of the HeartStart home defibrillator, which falls under a pre-amendments device category, says it is still preparing its response to FDA.

Others, having sent their summaries to the agency, have now only to wait for further FDA action. In the meantime, it's business as usual, firms say.

Pre-amendments devices, which fit into product categories that were on the market before FDA device regulations were established in 1976, were grandfathered into FDA's review system as high-risk class III products, but without the requirement for new devices to undergo PMA safety and effectiveness review. It was left up to FDA to either affirm the class III designation and mandate PMAs or reclassify the devices.

While FDA has formally classified many pre-amendments device types, 27 remain unaddressed. That these products can enter the market via the less-stringent 510(k) process is a point of concern for consumer advocates, members of Congress and the Government Accountability Office (2 'The Gray Sheet' Jan. 19, 2009).

Makers of 25 of the 27 types of devices must submit information supporting reclassification, or submit more detailed information if the firm has no data to support down-classifying.

Now that some data is in, the next step for FDA is "a great deal of review," an agency spokeswoman explained. The agency will assess the documents for sufficiency, redact them and post them online.

- Jessica Bylander

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